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EC number: 431-060-1 | CAS number: 153719-38-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August - October 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study follows OECD 401 acute toxicity which is now deleted (in 2002). But the authors state that the original OECD protocol is followed and it is carried out to GLP standards. Only two doses were tested so no dose-response relationship is reported. The LD50 lies between 1000 and 2000 mg/l. Use of control organisms is unreported.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- use of control animals is unreported; only two doses
- GLP compliance:
- yes
- Remarks:
- This study was performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerland.
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 431-060-1
- EC Name:
- -
- Cas Number:
- 153719-38-1
- Molecular formula:
- C4H8N4O3
- IUPAC Name:
- 3-methyl-N-nitro-3,6-dihydro-2H-1,3,5-oxadiazin-4-amine
- Details on test material:
- - Name of test material (as cited in study report): CA 2343 A (intermediate of CGA 293343)
- Physical state: fine, white powder
- Analytical purity: 96.7 %
- Batch No.: P. 503005
- Storage condition of test material: 0 - 5 °C
- Date of reanalysis: December 1996
- Test material received: August 16, 1995
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, Stein, Switzerland
- Age at study initiation: young adults
- Weight at study initiation: 174 - 217 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, with standardized soft wood bediing (Societe Parisienne des Sciures, Pantin, Paris); animals were segregated by sex and group-housed (5 animals per cage)
- Animal identification: color code on the tail (dash-dot code, painted with a felt-tipped waterproof marker)
- Diet: ad libitum (NAFAG 890, NAFAG, Gossau/SG, Switzerland)
- Water: ad libitum
- Acclimation period: at least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
- Details on oral exposure:
- VEHICLE
- Volume applied: 10 ml/kg body weight
- concentration of test substance in vehicle: 100mg/ml and 200mg/ml
Dose Levels, sex group:
- 1000 mg/kg body weight, males and females
- 2000 mg/kg body weight, males and females
- Rationale for dose selection: the dose level was selected according to OECD 401 and pretest results - Doses:
- 1000 and 2000 mg/kf body weight
- No. of animals per sex per dose:
- 5 animals per sex per dose;
total number of animals: 20 (10 males/10 females) - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (signs and symptoms): daily for 14 days
- Frequency of observations (mortality): daily; a.m. and p.m. on working days, a.m. on weekends
- Frequency of weighing: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- Mean and standard deviations of body weight changes
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Mortality:
- - 2000 mg/kg: 3 of 5 males and all females were found dead within 7 hours after administration of the test article
- 1000 mg/kg: all animals survived to the scheduled sacrifice - Clinical signs:
- other: IN-LIFE OBSERVATIONS: - 2000 mg/kg, males and females: dyspnea, reduced locomotor activity, convulsions, hunched posture and piloerection - 2000 mg/kg, individual males: tremor, ataxia, diarrhea and vental recumbency; surviving males recovered within 3 da
- Gross pathology:
- - spontaneously dying animals were submitted to a gross necropsy as soon as possible
- at necropsy, no deviations from normal morphology were found in all animals - Other findings:
- None
Any other information on results incl. tables
Body weight and necropsy findings:
1000 mg/kg, males
Animal Number |
Body weights (g) Day 0 7 14 |
* |
Gross Necropsy Findings |
||
1 2 3 4 5
mean SD |
195 198 194 195 211
199 7.1 |
231 247 228 231 248
237 9.7
|
295 293 289 279 302
292 8.5 |
TS TS TS TS TS |
no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities |
1000 mg/kg, females
Animal Number |
Body weights (g) Day 0 7 14 |
* |
Gross Necropsy Findings |
||
1 2 3 4 5
mean SD |
184 191 174 180 190
184 7.1 |
202 196 199 192 204
199 4.8 |
215 204 218 216 215
214 5.5 |
TS TS TS TS TS |
no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities |
* TS terminal sacrifice
2000 mg/kg, males
Animal Number |
Body weights (g) Day 0 7 14 |
* |
Gross Necropsy Findings |
||
1 2 3 4 5
mean SD |
196 210 208 205 217
207 7.7 |
239 236
238 2.1 |
284 284
284 0.0 |
7h TS TS 2h 24h |
no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities |
2000 mg/kg, females
Animal Number |
Body weights (g) Day 0 7 14 |
* |
Gross Necropsy Findings |
||
1 2 3 4 5
mean SD |
187 202 197 194 189
194 6.1 |
|
|
4h 5h 5h 5h 24h |
no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities no observable abnormalities |
* TS terminal sacrifice
* <> found dead < > hours after administration
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- At 2000 mg/kg CA 2343 A (intermediate of CGA 293343) elicited evident signs of acute toxicity and mortality in male and female rats. Signs of acute toxicity, but no mortality, were seen after treatment with 1000 mg/kg. CA 2343 A is classified as Acute Tox. 4.
- Executive summary:
In an acute oral toxicity study (OECD 401), groups of 10 fasted young adult albino rats (Tif: RAI f (SPF)) of both sexes (5 animals per group) were given (gastric intubation) a single oral dose of CA 2343 A (intermediate of CGS 293343) in 0.5 % (w/v) carboxymethylcellulose (in 0.1 % (w/v) aqueous polysorbate 80) in concentrations of 1000 mg/kg bw and2000 mg/kg bw. The animals were observed for a period of 14 days after administration of the test substance. The following LD50 was determined for CA 2343 A:
Oral LD50 Males > 1000 and < 2000 mg/kg bw
Females > 1000 and < 2000 mg/kg bw
Sexes combined > 1000 and < 2000 mg/kg bw
At 2000 mg/kg, 3 of 5 males and all females were found dead within 7 hours after administration. At 1000 mg/kg all animals survived to the scheduled sacrifice.
In-life observations indicating treatment related systemic effects such as dyspnea, reduced locomotor activity, convulsions, hunched posture and piloerection were recorded in both sexes at 2000 mg/kg. Tremor, ataxia, diarrhea and vental recumbency were limited to individual males. Surviving animals recovered within 3 days. At 1000 mg/kg, in-life observations such as reduced locomotor activity, hunched posture and piloerection were recorded in both sexes. All animals recovered within 6 days.
Body weights of surviving animals were unaffected by the treatment.
At necropsy, no deviations from normal morphology were found in all animals.
The LD50 was determined by linear interpolation to be 1500 mg/kg bw for females and 1830 mg/kg bw for males. Therefore, CA 2343 A is classified as Acute Tox. 4.
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